Ex Parte 6877530 et al

Board of Patent Appeals and Interferences

Aug 24, 2012

95000335 (B.P.A.I. Aug. 24, 2012)

UNITED STATES PATENT AND TRADEMARKOFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
95/000,335 01/11/2008 6877530 20010-013RX1 6157
76808 7590 08/24/2012
Leason Ellis LLP
One Barker Avenue
Fifth Floor
White Plains, NY 10601-1526
EXAMINER
WILLIAMS, CATHERINE SERKE
ART UNIT PAPER NUMBER
3993
MAIL DATE DELIVERY MODE
08/24/2012 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

INTELLIGENT HOSPITAL SYSTEMS LTD.
Requester and Appellant

v.

FORHEALTH TECHNOLOGIES, INC.
Patent Owner and Respondent

____________________

Appeal 2012-002609
Inter partes Reexamination Control No. 95/000,335
U.S. Patent 6,877,530 B2
Technology Center 3900
____________________

Before, KARL D. EASTHOM, KEVIN F. TURNER, and JONI Y. CHANG,
Administrative Patent Judges.

CHANG, Administrative Patent Judge.

DECISION ON APPEAL
Appeal 2012-002609
Reexamination Control No. 95/000,335
U.S. Patent 6,877,530 B2

2

STATEMENT OF THE CASE
This proceeding arose from a request for inter partes reexamination of U.S.
Patent 6,877,530 B2
1
filed on January 11, 2008. Third-Party Requester, Intelligent
Hospital Systems Ltd., appeals under 35 U.S.C. §§ 134(c) and 315(b) from the
Right of Appeal Notice
2
indicating that amended claims 1-15 and new claims
21-40 in the reexamination of U.S. Patent 6,877,530 B2 are patentable over the
cited prior art references. (App. Br. 8.)
3
The Patent Owner, ForHealth
Technologies, Inc., filed a respondent brief, and is a party to this appeal under 35
U.S.C. § 315(a)(2). (Resp. Br.)
4
No litigation involving the ‘530 Patent has been
identified. (App. Br. 4.) We heard oral arguments from both Requester and Patent
Owner on April 10, 2012, a written transcript of which was entered into the
electronic record on July 9, 2012.
We have jurisdiction under 35 U.S.C. §§ 134(c) and 315(b). We reverse.
Since our reversal of the Examiner’s decision not to adopt the Requester’s
proposed rejections of claims 1-15 and 21-40 constitutes a new ground of rejection,
our decision is not final for purposes of further judicial review. See 37 CFR
§ 41.77(b).

1
U.S. Patent 6,877,530 issued to Osborne et al. on Apr. 12, 2005, from
Application 10/457,066, filed Jun. 5, 2003 ( “the ‘530 Patent”).
2
Right of Appeal Notice (“RAN”) dated on Mar. 30, 2010. Examiner’s Answer
dated Sept. 29, 2010 (“Ans.”) incorporates by reference the RAN.
3
Appeal Brief filed on July 14, 2010 (“App. Br.”).
4
Patent Owner’s Respondent Brief filed August 10, 2010 (“Resp. Br.”).
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The Invention
The ‘530 Patent relates to a medication preparation system having a plurality
of stations for filling syringes. (Col. 3:66 to 4:2; figs 1 and 3.) The system
includes an automated device for controlling the movement of the syringe plunger
to fill the syringe with a liquid medication. (Col. 3:66 to 4:29; figs 7 and 9.)
Figure 3, reproduced below, illustrates an automatic syringe preparation system:

Figure 3 illustrates an automated medication preparation system in which a
plurality of syringes is indexed through the stations. (Col. 5:6-24.) The system
includes a syringe storage station 120, a rotary apparatus 130 for advancing the fed
syringes to various stations, and a station 155 that includes an automated device
700 for extending the plunger 50 of the syringe 10 a prescribed amount. (Col.
5:25-45; Col. 15:5-10.) The automated device 700 is connected to a programmable
controller 470. (Col. 15:11-17.) The device 700 includes an automated puller 800
that engages the plunger 50 and extends it a calculated distance based on a number
of parameters that are inputted into the controller 470. (Col. 15:18-27.)
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Representative Claims on Appeal
Claims 1 and 22 are representative of the subject matter on appeal:
1. (Once Amended) In an automated syringe preparation system in which
a syringe undergoes processing at plural stations while seated in an indexed
apparatus that moves the syringe from one station to another station, [An] an
automated device for extending a plunger of [a] the syringe a defined
distance within a syringe barrel based upon inputted syringe information, the
device comprising:
a housing having an adjustable plunger extension mechanism
positioned to automatically receive and engage the seated syringe as it is
advanced in the automated system;
[an] the adjustable plunger extension mechanism [that includes]
including a movable component that intimately engages the plunger so that
movement of the component is translated into extension of the plunger of the
seated syringe, the component including a controllable drive that moves the
component the defined distance;
a controller that receives the inputted syringe information and
calculates the defined distance that the plunger is moved based on the
inputted syringe information and instructs the controllable drive to move the
plunger the defined distance; and
a sensor device for monitoring whether a permitted length of travel of
the movable component is such that the movable component has been driven
to a maximum position, the sensor device being independent and stationary
relative to the movable component.
22. (New) The automated device of claim 16
5
, wherein the controller includes a
calibration table to determine the defined distance that the plunger is to be
moved and wherein the input includes a customer code that indicates that
special instructions have been supplied by a customer including the overfill
value.
(Amendment 2 and 8.)
6

5
Claim 16 has been determined by the Examiner to be unpatentable, and the
rejection is not on appeal. (RAN 12-17; App. Br. 5).
6
Patent Owner’s Amendment filed on June 7, 2008 (“Amendment”).
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Prior Art Relied Upon
The Requester relies upon the following evidence:
Hochman et al. U.S. Patent No. 6,200,289 B1, issued on Mar. 13, 2001.
Ortiz et al. U.S. Patent No. 5,884,457, issued on Mar. 23, 1999.
McConnell et al. U.S. Patent No. 5,363,885, issued on Nov. 15, 1994.
Margrey et al. U.S. Patent No. 5,366,896, issued on Nov. 22, 1994.
Zezulka et al.
PCT International Application Publication WO
90/09776, published on 7 Sept. 1990.
Hardie et al. U.S. Patent No. 5,479,969, issued on Jan. 2, 1996.
Baldwin et al.
U.S. Patent Application Publication 2002/0020459 A1,
published on Feb. 21, 2002.
Torchia et al. U.S. Patent No. 5,431,201, issued on Jul. 11, 1995.
Fonss et al. U.S. Patent No. 5,004,962, issued on Apr. 2, 1991.
Rao et al. U.S. Patent No. 5,948,360, issued on Sep.7, 1999.
Ross U.S. Patent No. 3,965,945, issued on June 29, 1976.
Hennessey et al. U.S. Patent No. 4,706,207, issued on Nov. 10, 1987.
Kircher et al.
U.S. Patent Application Publication 2002/0035412,
published on Mar. 21, 2002.
Cassel U.S. Patent No. 5,911,252, issued on Jun. 15, 1999.
Carter U.S. Patent No. 5,288,285, issued on Feb. 22, 1994.

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Issues on Appeal
Based on the issues raised by the Requester and Patent Owner in their
arguments, we review the following issues in this appeal:
1. Whether one of ordinary skill in the art would have combined Hochman and
Ortiz to conclude that claims 1-15, 21, and 25-40 were obvious? (App. Br. 9-
13; Resp. Br. 7-13.; Rebuttal Br. 5-9.)
2. Whether the combination of Hochman, Ross, Hennessey, and/or Kircher
describes or suggests a calibration table and overfill instructions as recited in
claims 22-24? (App. Br. 13-17; Resp. Br. 13-14.; Rebuttal Br. 9-12.)
FINDINGS OF FACT
The findings of fact that appear in this opinion, including those fact findings
in the Analysis section, are supported by a preponderance of the evidence.
Ortiz
FF1. Ortiz describes an automated syringe preparation system for producing a
plurality of prefilled syringes. (Col. 5:43-67; figs. 1 through 7G). In
particular, the automated syringe preparation system 10 has a magazine
drive motor 52 (fig. 1) and drive carriage 46 (fig. 7A) that move a feeding
magazine 26 that holds a plurality of syringes 12 (col. 6:27-43; fig. 6) along
the path 44 (col. 7:21-42) through a plurality of stations including the tip
removing station 54, fluid filling station 66, and sealing station 84 in an
indexed manner (col. 12:4-15).
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FF2. Figure 7G of Ortiz, reproduced below, shows the automated system 10
includes a fluid filling station 66:

Figure 7G illustrates an automated syringe preparation system.
When the seated syringe 12 held by the feeding magazine 26 is positioned
over the fluid filling station 66, a signal is sent by the controller 60 to raise
the fluid filling station 66 upwardly into the second position to engage the
connector 76 with the dispensing nozzle 16 of the syringe 12. Once the
connector 76 and the dispensing nozzle 16 are engaged, the pump 70 is then
automatically pump fluid from the fluid source 82 into the hollow barrel 14
of the syringe 12. (Col. 10:1-19; figs. 1, 3A-3C, and 7A-7G.)
Hochman
FF3. Hochman describes an automated drive mechanism that controls the flow
rate and the amount of fluid that fills a syringe by controlling the movement
of the syringe plunger. (Col. 4:45-46; col. 5:49-59; fig. 1.)
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Baldwin
FF4. Baldwin also describes an automated apparatus for syringe preparation that
includes a plurality of stations. (¶0002 and figure 5.) Similar to Hochman’s
automated drive mechanism, Baldwin has a filling station that controls the
flow rate of the fluid by controlling the movement of the syringe plunger.
Specifically, figures 11d-11e of Baldwin, reproduced below, illustrate the
filling station 490 having a syringe flange retention track 492 and a plunger
flange retention member 494:

Figures 11d and 11e show syringe handling operations at the filling station.
As shown by the above figures, Baldwin’s the plunger flange retention
member 494 is selectively retractable relative to retention track 492 so that
fluid may be drawn from liquid dispensing apparatus 420 to fill syringes S.
(¶ 0103). Therefore, the distance that the plunger moves may be precisely
controlled to achieve a preset filling volume. (¶ 0106).

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PRINCIPLES OF LAW
Obviousness
“Section 103(a) forbids issuance of a patent when ‘the differences between
the subject matter sought to be patented and the prior art are such that the subject
matter as a whole would have been obvious at the time the invention was made to a
person having ordinary skill in the art to which said subject matter pertains.’” KSR
Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is
resolved on the basis of underlying factual determinations including (1) the scope
and content of the prior art, (2) any differences between the claimed subject matter
and the prior art, (3) the level of skill in the art, and (4) where in evidence, so-
called secondary considerations. Graham v. John Deere Co., 383 U.S. 1, 17-18
(1966).
ANALYSIS
We begin our analysis by determining the scope and content of the prior art.
Although the Patent Owner argues that the combination of Hochman and Ortiz
does not teach all the elements of claim 1, the Patent Owner did not point out
which element is not described by the collective teachings of the prior art
references. (Resp. Br. 8.) As noted by the Examiner, Hochman describes most of
the limitations recited in the claim. (RAN 4-5.) Further, Ortiz describes the other
limitations as follows:
(1) an automated syringe preparation system [10 in figs. 7A-7G; col.
5:45-48] in which a syringe [sterile delivery devices 12 in fig. 6; col.
5:55-57] undergoes processing at plural stations [e.g., tip removing
station 52, fluid filling station 66, sealing station 84, and dispensing
station 102 in in fig. 1; col. 12:4-15] while seated in an indexed
apparatus [feeding magazine 26 in fig. 6-7G] that moves the syringe
from one station to another station [the controller 60 actuates the
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magazine drive motor 52 to move the feeding magazine 26 along the
path 44 to pass each syringe 12 through the stations; col. 12:4-14; fig.
1 and fig. 7A]; and
(2) a housing [a housing 48 in fig. 7A] having an adjustable plunger
extension mechanism [fluid filling station 66 in figs. 3A-3C and 7D-
7G; col. 9:13-27] positioned to automatically receive and engage the
seated syringe as it is advanced in the automated system [fluid filling
station 66 in figs. 3A-3C; col. 10:1-16].

Given that, we agree with the Requester that the collective teachings of Hochman
and Ortiz describe all of the limitations recited in claim 1. (App. Br. 10.)
Issue 1: Claims 1-15, 21, and 25-40
Requester argues that the claimed invention would have been obvious in
view of the combination of Hochman and Ortiz. (App. Br. 9-13.) Specifically, the
Requester states that one skilled in the art would have been motivated to combine
the teachings of Hochman and Ortiz “by the desirability of preparing multiple
medication syringes in an organized and automated manner.” (App. Br. 12.) The
Requester further states that Hochman and Ortiz are reasonably pertinent to the
problem that the inventor of the ‘530 patent was trying to solve (i.e., “filing
syringes with medication doses in an automated manner”). (App. Br. 10; Rebuttal
Br. 6.) The Requester also argued that combining Hochman and Ortiz would
predictably yield “a system that provides a series of indexed syringes for delivery
to one or more patients.” (App. Br. 11-12; Rebuttal Br. 7-9.)
The Examiner did not adopt the proposed rejection of claims 1-11, 21, and
36 as unpatentable over the combination of Hochman and Ortiz because, according
to the Examiner, one of ordinary skill in the art would not have been motivated to
combine Hochman with Ortiz. (RAN 5-7.) In particular, the Examiner finds that
Hochman teaches an automated injection device for drug delivery to a single
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patient whereas Ortiz teaches a system for automatically producing a plurality of
liquid filled syringes. (RAN 6-7.) The Examiner further finds that incorporating
the indexed apparatus of Ortiz into the Hochman’s device would destroy the
Hochman device’s principle of operation (i.e., drug delivery) and there is no
motivation to modify Hochman’s device to provide a plurality of liquid filled
syringes. (RAN 6-7.)
The Patent Owner agrees with the Examiner’s determination. (Resp. Br. 8-
13.) We, however, find the Requester’s arguments convincing.
We note that “[i]t is well-established that a determination of obviousness
based on teachings from multiple references does not require an actual, physical
substitution of elements.” In re Mouttet, No. 2011-1451, Slip op. at 15 (Fed. Cir.
June 26, 2012). As such, we do not agree that Ortiz’s automated syringe
preparation system must be bodily incorporated into Hochman’s automated drive
mechanism. In re Etter, 756 F.2d 852, 859 (Fed. Cir. 1985) (en banc); In re Keller
642 F.2d 413, 425 (Obviousness does not require that all of the features of the
secondary reference be bodily incorporated into the primary reference.). Further,
the assertion that Hochman’s principle of operation must be preserved is incorrect
because it is based on the incorrect assumption that Hochman must remain as the
“primary reference” and Ortiz must remain as the “secondary reference.” See In re
Mouttet, Slip op. at 16 (“where the relevant factual inquiries underlying an
obviousness determination are otherwise clear, characterization by the examiner of
prior art as ‘primary’ and ‘secondary’ is merely a matter of presentation with no
legal significance.”); see also In re Bush, 296 F.2d 491, 496 (CCPA 1961)
(Rich, J.).
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Rather, we find that one of ordinary skill in the art would have modified
Ortiz’s automated indexed apparatus in view of Hochman, specifically
implementing Hochman’s syringe plunger control system at the fluid filling
station. Therefore, the Ortiz’s system would fill each syringe automatically by
controlling the movement of the syringe plunger to regulate the flow rate and
volume of the fluid based on the input information. Such modification would
enhance the Ortiz system’s principle of operation, i.e., automatically filling a
plurality of syringes and precisely controlling the flow rate of the liquid to achieve
a preset volume.
We also agree with Requester that modifying Ortiz’s automated syringe
preparation apparatus in view of Hochman produces a predictable result. (App. Br.
11-12; Rebuttal Br. 7-9.) It was known in the art at the time of the invention that
an automated syringe plunger control device (similar to Hochman’s system) may
be operated in a syringe filling station of a mass production apparatus. See
Baldwin, FF4. Further, we find that the prior art references, such as Ortiz and
Hochman, demonstrate that the automated syringe preparation system recited in
claim 1 can be formed using components known in the art and the components
have been combined for their respective functions. For instance, Ortiz teaches an
automated indexed apparatus 10 (including a feeding magazine 26 and fluid filling
station 66) for carrying and moving a syringe 12 from one station to another and
for receiving and engaging the syringe 12 automatically at the fluid filling station
66 (Ortiz, figs. 3A-3C and 6-7G). Hochman teaches a syringe plunger control
system for controlling the movement of a syringe plunger to control the flow rate
and volume of the fluid (Hochman, figs 1-4). See KSR, 550 U.S. at 417 (“[W]hen
a patent ‘simply arranges old elements with each performing the same function it
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had been known to perform’ and yields no more than one would expect from such
an arrangement, the combination is obvious.”) (citing Sakraida v. AG Pro, Inc.,
425 U.S. 273, 282 (1976)).
As to the Patent Owner’s assertion that Hochman is an injection device for
drug delivery into a single patient, we do not find Hochman’s teachings so limited.
A reference may be read for all that it teaches, including uses beyond its primary
purpose. KSR, 550 U.S. at 416; In re Burckel, 592 F.2d 1175, 1179 (CCPA 1979).
Here, in the alternative embodiment, Hochman’s automated syringe plunger
control system (that includes a drive mechanism 12 connected to a control unit 18)
may be used for controlling the plunger 94 to draw fluid into the syringe. See e.g.,
Hochman col. 4:39-49; 5:49-54; 13:48-14:9; fig. 1. Thus, one of ordinary skill in
the art would have recognized that Hochman’s automated syringe plunger control
system could be used for filling a syringe with a fluid. Id. Such an artisan could
use the Hochman system to control the movement of the syringe plunger to
regulate the flow rate and to control the volume of the fluid being drawn into the
syringe based on user input information (e.g., the type of syringe being used). Id.
Patent Owner also argues that Ortiz is not directed to a device that operates a
syringe plunger in an automated manner. (Resp. Br. 8-9.) In the Patent Owner’s
view, “Ortiz fills the syringes through the dispensing nozzle and, as a result, the
syringe piston plunger 18 moves passively in reaction to the filling operation
without ever being engaged by anything.” Id. Patent Owner further alleges that
“syringe of Hochman is part of a pump that cannot automatically receive and
engage an already seated syringe.” Id. at 10-11. Specifically, Patent Owner
contends that Hochman “discloses a purely manual method of loading the syringe
onto the device that moves the plunger.” Id.
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We do not find the Patent Owner’s arguments compelling because
nonobviousness cannot be established by attacking the references individually
when the rejection is based upon a combination of prior art disclosures. See In re
Merck & Co. Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Here, in the combination
of Hochman and Ortiz, the syringe would be seated in Ortiz’s feeding magazine 26
and moved from one station to another by Ortiz’s drive motor 52 and drive
carriage 46 (figs. 6-7G), and Hochman’s drive mechanism 12 would be operating
and engaging the syringe plunger at Ortiz’s fluid filling station (similar to
Baldwin’s second embodiment discussed at ¶¶ 0103-0106 and illustrated in figs.
11a-11h, and the Requester’s second figure on page 8 of the Rebuttal Brief).
The Requester proffers several reasons as to why one ordinary skill in the art
would have been led to combine Hochman’s automated mechanism device with
Ortiz’s automated syringe preparation apparatus. (App. Br. 12.) The Requester
further articulates the following advantage (id.):
The collection of syringe specific information and determination of the
defined distance of travel of the syringe plunger based on the inputted
syringe information, as described by Hochman, could benefit the
functionality of the fluid filling station of Ortiz, for example, by providing
an extra level of quality assurance, especially in the circumstance of filling
various sizes of syringes within a batch operation.

Given that and the advantages of automating the manual process of filling
syringes stated in the prior art (e.g., Ortiz col. 1:11-17 and Baldwin ¶ 0003), we
find there are sufficient reasons based on rational underpinnings to explain why
one of ordinary skill in the art would have been led to modify Ortiz’s automated
indexed syringe preparation apparatus in view of Hochman.
For the foregoing reasons, one of ordinary skill in the art would have found
the subject matter in claim 1 obvious. The Requester and Patent Owner did not
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provide separate arguments for claims 2-11, 21, and 36. Accordingly, we reverse
the Examiner’s refusal to adopt the proposed rejection of claims 1-11, 21, and 36
as unpatentable over the combination of Hochman and Ortiz.
As to claims 12-15, the Examiner did not adopt the proposed rejection of
claims 12-15 for the same reasons given with respect to claim 1. (RAN 8-10.) The
Examiner further states that (RAN 10):
However, neither Hochman nor Fonss teach [sic] “an automated
syringe preparation system in which a syringe undergoes processing at
plural stations while seated in an indexed apparatus that moves the
syringe from one station to another station” and where the adjustable
plunger extension mechanism is positioned to automatically receive
and engage the seated syringe as it is advanced in the automated
system.

These limitations are recited in claim 1. The Requester proposed that claim 12
should be rejected for the same reasons given with respect to claim 1.
7
Claims 13-
15 depend from claim 12. Further, the Requester and Patent Owner did not
provide separate arguments for claims 12-15. (App. Br. 9-13; Resp. Br. 13.)
As discussed previously, we find that Ortiz teaches these limitations, and
one of ordinary skill in the art would have combined Ortiz and Hochman and
found the subject matter in claim 1 obvious. We therefore reverse the Examiner’s
refusal to adopt: (1) the proposed rejection of claim 12 as unpatentable over the
combination of Hochman and Ortiz in view of Fonss; and (2) the proposed
rejection of claims 13-15 as unpatentable over the combination of Hochman and
Ortiz in view of Fonss and Rao.

7
Third Party Comments on Patent Owner Response filed on July 7, 2008 (“3PR
Comments”), page 6.
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As to claims 25-27 which depend from claim 1, the Examiner did not adopt
the proposed rejection for the same reasons given as to claim 1. (RAN 19.)
Specifically, the Examiner states that the proposed rejection of claims 25-27 over
Hochman in view of Cassel does not solve the deficiencies of amended claim 1.
Id. The Requester and Patent Owner provide no separate argument for claims 25-
27. (App. Br. 9-13; Resp. Br. 13.)
As discussed previously, one or ordinary skill in the art would have found
the subject matter of claim 1 obvious in view of the combination of Hochman and
Ortiz. We therefore reverse the Examiner’s refusal to adopt the proposed rejection
of claim 25-27 as unpatentable over the combination of Hochman and Ortiz in
view of Cassel.
As to claims 28-35, and 37-40, the Examiner did not adopt the proposed
rejections for the same reasons given with respect to claim 1. (RAN 20-21.) The
Requester and Patent Owner do not provide separate arguments for these claims.
(App. Br. 9-13; Resp. Br. 13.)
Claim 28 depends from independent claim 16, and claims 29 and 38-40
depend from claim 16 through claim 28. Claim 30 depends from independent
claim 19, and claims 31-34 depend from claim 19 through claim 30. Claim 35
depends from claim 1, and claim 37 depends from claim 1 through claim 36.
The Examiner rejects independent claims 16 and 19 as being unpatentable
over Hochman in view of Ross. (RAN 12-16 and 22-23.) These rejections,
however, are not being appealed by the Patent Owner.
Claims 28 and 30 further recite “wherein the automated device for extending
the plunger is part of an automated syringe preparation system in which the syringe
undergoes processing at plural stations…” These limitations also appear in
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claim 1. As discussed previously, we find that Ortiz teaches these limitations and
one of ordinary skill in the art would have combined Hochman and Ortiz, and
found the subject matter in claim 1 obvious.
Accordingly, we reverse the Examiner’s refusal to adopt: (1) the proposed
rejections of claims 28-34 and 38-40 as unpatentable over the combination of
Hochman and Ortiz in view of Ross, and in further view of McConnell, Margrey,
Zezulka, Hardie, Baldwin, and/or Torchia; and (2) the proposed rejection of claims
35 and 37 as unpatentable over the combination of Hochman and Ortiz in view of
Baldwin.
Issue 2: Claims 22-24
The Examiner refuses to adopt the proposed rejection of claims 22-24 as
unpatentable over Hochman in the combination of Ross, Hennessey or Kircher
because the references do not describe a calibration table as recited in claim 22.
(RAN 17.) In particular, the Examiner does not find Hochman’s data bank to be a
calibration table as recited in claim 22. (RAN 17.) The Requester however argues
that Hochman teaches substantially the same approach as the ‘530 patent, using
information in a table that contains physical characteristics of the syringes and user
inputs to determine the distance the syringe plunger travels. (App. Br. 13.) We
find the Requester’s argument convincing.
We first review the Specification of the ‘530 Patent to determine the
meaning of the term “a calibration table.” The ‘530 Patent provides that “[t]he
software of the programmable control is written so that it contains calibration
tables for various syringe types.” (Col. 21:21-23.) The ‘530 Patent also provides
the following (col. 20:60-col. 21:8):
Unlike many of the conventional automated systems, the present
system provides many more options for the user and also permits the
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distance that the plunger is extended to be readily changed. More
specifically, the user only has to input the necessary information, such
as the syringe type, and because the controller is a programmable unit,
it includes databases of information. The controller accesses these
databases and is able to retrieve the syringe characteristics based on
the limited information that the user provided. For example, the barrel
diameter and the volume specifics about the barrel are determined and
then based on the inputted desired (target) volume of the prescribed
dose, the controller computes the distance that the plunger needs
to be extended in order to form a dosage receiving space of sufficient
and optimal dimension.

Given that, we recognize that the distance that the plunger needs to be moved is
calculated by the controller, rather than the calibration table. The controller
calculates the distance based on the inputted desired volume of the medication and
the syringe characteristics (e.g., barrel diameter) retrieved from the databases,
given the user input information (e.g., the syringe type). The disclosure of the ‘530
Patent implies that the calibration tables are the databases used to calculate the
distance that the plunger needs to be moved. Therefore, one of ordinary skill in the
art would have recognized that a calibration table contains the syringe type and the
syringe characteristics for that particular syringe type.
Similar to the calibration table of the ‘530 Patent, Hochman’s data bank
contains the syringe types and the syringe characteristics. Specifically, Hochman
describes a memory 160 that is used to store programming and data for the master
microprocessor 152 (which is part of the controller 150). (Col. 8:17-18 and 38-
44.) The memory 160 stores data banks that contain the following information:
(a) syringes; (b) tubing; (c) needles; (d) fluids; (e) governor parameters; and (f)
profiles consisting of a plurality of parameters for a particular procedure to be
performed. Id. Once a syringe is selected, its physical characteristics such as
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19
length, nominal volume, stroke length, syringe force are retrieved from the data
bank and displayed as shown in Fig. 12A. (Col. 9:38-43.) The master
microprocessor 152 may be programmed to perform the calculations necessary to
generate the profiles. (Col. 10:32-37.) For filling a syringe, the system controls
the motor to run for a predetermined time causing the plunger 94 to move for the
predetermined distance. (Col. 13:58-col. 14:9.) Given those teachings, one of
ordinary skill in the art would have recognized that Hochman’s controller uses the
data bank to calculate the distance that the plunger needs to be moved. Therefore,
we conclude that Hochman describes the limitation “wherein the controller
includes a calibration table to determine the defined distance that the plunger is to
be moved” as recited in claim 22.
The Patent Owner additionally argues that Hochman fails to describe the
following element in claim 22: “wherein the input includes a customer code that
indicates that special instructions have been supplied by a customer including the
overfill value.” (Resp. Br. 14.) According to the Patent Owner, Hochman fails to
describe such a feature because the syringe used in Hochman is prefilled when
introduced into the Hochman device. Id.
We are not persuaded by Patent Owner’s arguments. First, the Patent
Owner’s argument relies on the preferred embodiment of Hochman for drug
delivery into a single patient, and fails to recognize other teachings in Hochman.
As previously discussed, Hochman’s alternative embodiment describes an
automated syringe plunger control system that could be operated to drawn fluid
into the syringe electronically based on user input information. Therefore, the
syringe used in Hochman’s alternative embodiment is not prefilled.
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20
Second, as the Examiner points out, Ross specifically teaches the concept of
syringe overfill in order to assure ejection of an entrapped air from the syringe
during filling the syringe. (RAN 14, citing to Ross col. 4:12-41.) The Examiner
also articulates the reason as to why one of ordinary skill in the art would have
combined the teachings of Hochman and Ross is to assure the consistent filling of
syringes with absolute correct dosages of medicament as provided by Ross (col.
5:4-7). (RAN 14.) Thus, one of ordinary skill in the art at the time of invention
would have been led to include an additional variable overfill value, depending on
the type of syringe and fluid being filled, in Hochman’s control system, as taught
by Ross, in order to assure ejection of any entrapped air from the syringe during
filling of the syringe. (RAN 14; see also Ross col. 5:4-7.)
We further find that it is well known in the art that an automated system can
be programmed to slightly overfill the syringe (see e.g., Hennessy, col. 12:31-33),
and an automated medication preparation apparatus may be adjusted for a user
defined overfill volume by increasing the volume of the medication so that the
correct amount of medication will in fact be delivered to the patient (Kircher, ¶
0115).
Given the collective teachings of the prior art references, one of ordinary
skill in the art would have been led to program Hochman’s automated plunger
control system, specifically the controller, to slightly overfill the syringe based on
a user defined overfill volume so that the correct amount of medication will be
delivered to the patient.
For the foregoing reasons, we reverse the Examiner’s refusal to adopt the
proposed rejection of claims 22-24 as unpatentable over Hochman in view of Ross,
Hennessey or Kircher.
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21
CONCLUSION
We reverse the Examiner’s refusal to adopt the following proposed
rejections:
(1) The proposed rejection of claims 1-11, 21, and 36 as unpatentable over
the combination of Hochman and Ortiz;
(2) The proposed rejection of claim 12 as unpatentable over the combination
of Hochman and Ortiz in view of Fonss;
(3) The proposed rejection of claims 13-15 as unpatentable over the
combination of Hochman and Ortiz in view of Fonss and Rao;
(4) The proposed rejection of claim 25-27 as unpatentable over the
combination of Hochman and Ortiz in view of Cassel;
(5) The proposed rejections of claims 28-34 and 38-40 as unpatentable over
the combination of Hochman and Ortiz in view of Ross, and in further view of
McConnell, Margrey, Zezulka, Hardie, Baldwin, and/or Torchia;
(6) The proposed rejection of claims 35 and 37 as unpatentable over the
combination of Hochman and Oritz in view of Baldwin; and
(7) The proposed rejection of claims 22-24 as unpatentable over Hochman in
view of Ross, Hennessey or Kircher.

SUMMARY
We reverse the Examiner’s decision not to reject claims 1-15 and 21-40.
Under 37 C.F.R. § 41.77(b), the Board’s reversal of the Examiner’s decision not to
reject the claims constitutes a new ground of rejection.

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This decision contains new grounds of rejection pursuant to 37 C.F.R.
§ 41.77(b) which provides that “[a]ny decision which includes a new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review.” Correspondingly, no portion of the decision is final for purposes of
judicial review. A requester may also request rehearing under 37 C.F.R. § 41.79, if
appropriate, however, the Board may elect to defer issuing any decision on such
request for rehearing until such time that a final decision on appeal has been issued
by the Board.
37 C.F.R. § 41.77(b) also provides that the Patent Owner, WITHIN ONE
MONTH FROM THE DATE OF THE DECISION, must exercise one of the
following two options with respect to the new grounds of rejection to avoid
termination of the appeal as to the rejected claims:
(1) Reopen prosecution. The owner may file a response requesting
reopening of prosecution before the examiner. Such a response must be either an
amendment of the claims so rejected or new evidence relating to the claims so
rejected, or both.
(2) Request rehearing. The owner may request that the proceeding be
reheard under § 41.79 by the Board upon the same record. …

REVERSE
37 C.F.R. § 41.77(b)

lb
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PATENT OWNER:
LEASON ELLIS LLP
ONE BARKER AVENUE
FIFTH FLOOR
WHITE PLAINS, NY 10601-1526

THIRD-PARTY REQUESTER:
FISH & RICHARDSON P.C.
3200 RBC PLAZA
60 SOUTH SIXTH STREET
MINNEAPOLIS, MINNESOTA 55402